McIver v. Krischer.
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Conflict of interest is an issue that has been put in the spotlight by the commercial application of the new biomedical technologies. This paper presents the approach of the Council of Europe and the binding legal instruments to deal with this problem. The main focus is on the Convention on Human Rights and Biomedicine, and its draft additional Protocol on Biomedical Research.
How a society regulates Assisted Reproduction Technologies (ART) depends on cultural context. The challenge for the regulatory regime is to balance protection for patients and society with freedom for medico-scientific creativity. Neither an exclusively market-regulated nor a peer-regulated approach is realistic politically, or desirable socially, ethically and legally. Legitimate social issues that go beyond the exclusive expertise of doctors and scientists or market choice by patients need to be accommodated within the regulatory regime. Within this context, four key issues are discussed: the lack of a shared social ethic that helps the needs of the community to be balanced against those of its individual members; the negative impact of intrusive external regulation on scientists and doctors; the requirement for doctors and scientists to review their professional structures reflectively and critically if they are to be entrusted with peer-regulation; and the desirability of constructive dialogue between regulators and regulated rather than the use of coercion and criminal sanctions.
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In 1986, Congress passed legislation intended to prevent hospitals from "dumping" patients who were unable to pay for their care. This legislation was appended to the Consolidated Omnibus Budget Reconciliation Act as the Emergency Medical Treatment and Active Labor Act (EMTALA). The EMTALA imposes two sets of duties on all hospitals that receive Medicare funds. Since 98% of hospitals in the United States participate in the Medicare program, EMTALA applies to nearly all hospitals in the United States. In short, hospitals with an emergency department must provide an appropriate screening examination to any patient who requests treatment. The purpose of the medical screening examination is to determine whether an "emergency medical condition" exists. If an emergency medical condition is discovered, the hospital must either provide treatment sufficient to stabilize the patient's condition or transfer the patient to another medical facility in an acceptable fashion.
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An analysis of abortion law reform in all regions of the world in the past 20 years shows that countries have turned from a concentration upon criminality to a concern with women's health and family well-being. Pragmatic approaches to achieve liberalization of abortion laws are described. Where legal reform is unlikely, specification of professional medical standards, clarification of laws and the scope of allowable action, as well as supportive statements by government officials, can facilitate services and may ultimately have a positive influence on legal reform.
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This paper considers the potential benefits and harms of DNA patenting for biomedical research and medical practice. It argues that, all things considered, the benefits of patenting DNA outweigh the harms, although societies should adopt policies designed to prevent or mitigate the harms associated with patenting. Some of these policies include: (1) reinforcing the research exemption for academic researchers, (2) raising the "bar" for the criteria of patentability, (3) restricting the scope of patents, (4) disclosing conflicts of interest related to DNA patents, (5) sharing the economic benefits of patenting with patients, and (6) providing insurance coverage for some types of genetic tests.
The public attention to issues of academic and research misconduct requires that all faculty and students become familiar with the policy and procedural areas and roles of various officials in handling allegations of misconduct. Although the incidence of such misconduct seems to be small, issues of reporting, adjudication, rehabilitation, and deterrence are important to all with concern about the integrity of academic processes. Many issues concerning the management of allegations of academic or research misconduct remain unresolved. Examples include the definition of misconduct, provision for (or lack of) anonymity, the role of the whistleblower, the burden of proof, the statute of limitations, the nature and application of sanctions, and the processes of rehabilitation.
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Genetic researchers and medical practitioners often need to obtain access to stored human tissue without consent from the people concerned. But the laws that relate to the ownership of, and control over, stored human tissue are at present unclear, especially in the light of recent cases and inquiries. Here, I discuss how the law might be clarified, and argue that the law should allow stored human tissue to be used without consent, providing that this occurs with ethical approval and that the confidentiality of the donor is protected.